Intrauterine device

ABSTRACT

An intrauterine device providing a membrane to cover substantially the entire surface of the uterine cavity, said device having a Y- and or V-shaped resilient member with two diverging arms, a membrane covering the entire area between the diverging arms and, in addition, extending above an imaginary line passing through the terminal ends of the arms, and a flexible tail or string connected to the intersection of the arms for aiding in the removal of the device from the uterus when desired. Optionally, the arms may having a plurality of flexible spurs extending therefrom for maintaining the intrauterine device in position within the uterus.

This application is a division of application Ser. No. 549,584, filedFeb. 13, 1975, now U.S. Pat. No. 4,038,978.

FIELD OF THE INVENTION

This invention relates to intrauterine contraceptive devices. Moreparticularly, this invention relates to Y- or V-shaped intrauterinedevices of the type generally described in U.S. Pat. Nos. 3,507,274 and3,811,435. Related intrauterine devices are also described in U.S. Pat.Nos. 3,253,590, 3,633,574, and 3,645,258.

SUMMARY OF THE INVENTION

The intrauterine device of this invention includes a resilient Y- orV-shaped member having two arms gradually and continuously divergingupwardly and outwardly from the intersection thereof adjacent the baseportion of the resilient member. The arms are sufficiently resilient sothey can be urged together when the intrauterine device is drawn into aninserter prior to insertion of the intrauterine device into the uterus.Upon insertion into the uterus, the arms, due to the resilient naturethereof, return to their original uncompressed shape. In this condition,the outer surfaces thereof contact the adjacent sidewalls of the uterusin such a manner that the device is desirably retained within theuterus. If the resilient member is not plastic, it is preferably encasedin a plastic or rubber material, such as, for example, medical grade orclean grade silicone rubber. A thin flexible membrane or web extendsbetween the two diverging arms and covers not only the entire areabetween the arms but extends above them in a generally rectangularfashion, although other shapes and configurations are contemplated asbeing within the scope of this invention. The function of the membraneis to contact all or substantially all of the surface area of the uterusthereby preventing nidation or implantation of a fertilized ovum. Inaddition, the higher membrane enables the intrauterine device to betailored (i.e., as by cutting) to the exact size of the uterus, therebysubstantially eliminating areas of the uterus not adjacent to theintrauterine device where implantation can occur. Optionally, ratherthan cutting the membrane prior to insertion, the membrane is made ofmaterial which is sufficiently flexible such that, if it reaches thefundus upon insertion, it will fold back upon itself and thus completelyfill the uterus, once again eliminating areas for implantation of afertilized ovum. The membrane, extending as it does above the ends ofthe arms, enables the intrauterine device of this invention to beutilized with both larger and smaller uteri, thus obviating the need tomanufacture devices of different size and shape.

Adjacent to the intersection at the base portion of the device, theremay be a pair or plurality of flexible spurs or protuberances extendingfrom the arms which are intended to assist in preventing expulsion ofthe device once it is in position within the uterus. Unlike the spurs oncertain known, commercially-available devices which are rigid, the spurscontemplated hereby are soft and flexible so as not to penetrate theendometrial lining of the uterus.

A flexible tail or monofilament string is connected to the intersectionat the base portion of the device and is grasped when it is desired toremove the device from the uterus. A monofilament string is preferablyutilized since such a string is of substantially smaller dimension thanthe flexible tail shown, for example, in U.S. Pat. Nos. 3,507,274 and3,811,435 and, accordingly, will cause less irritation when in positionin the cervical os, offer less surface area for growth ofinfection-causing microorganisms and will cause less dilation of theupper endocervical canal thereby reducing partial expulsion of thedevice. In addition, with devices having a flexible tail, it isnecessary to push the intrauterine device into the inserter (see, forexample, FIG. 1 of U.S. Pat. No. 3,507,274 and FIGS. 1, 3 and 5 of U.S.Pat. No. 3,811,435). With a monofilament string, the intrauterine deviceis pulled into the inserter by pulling on the string after it isthreaded through the hollow plunger of the inserter. This techniqueobviates the need for sterile gloves which can be a problem in remoteareas of underdeveloped countries.

In one embodiment, the intrauterine device of this invention includes aresilient Y- or V-shaped member having two arms gradually andcontinuously diverging upwardly and outwardly from the intersectionthereof adjacent the base portion of the resilient member, each of thearms being, at the uppermost portion thereof, curved outwardly,downwardly, and inwardly to form a bent-back portion in the form of apartial loop terminating short of contacting the body of the adjacentarm. The resilient member is totally encased in a plastic or rubbermaterial, preferably, silicone rubber, the encasement about each of thepartial loops being in the form of a bead having a flat surface parallelto a plane passing through the resilient member and a curved outsidesurface along the bent-back portion, the curved outside surface beingadapted to contact the adjacent side wall of the uterus when theintrauterine device is in position within the uterus.

In a further embodiment, the intrauterine device of this inventionincludes a resilient Y- or V-shaped member having two arms gradually andcontinually diverging upwardly and outwardly from the intersectionthereof adjacent the base portion of the resilient member, each of thearms terminating, at the uppermost portion thereof, in a relativelybulbous end portion. Each bulbous end portion has a flat surfaceparallel to a plane passing through the resilient member and curved sidesurface adapted to contact the adjacent sidewall of the uterus when theintrauterine device is in position within the uterus, such contactduring use being due to the resilient nature of the arms.

The bulbous end portions or beads should be sufficiently small so as notto render insertion of the device unusually painful. If desired, thebulbous end portions or beads can be eliminated; however, they doprovide curved, smooth surfaces for contact of the device with theadjacent sidewalls of the uterus and, thereby do serve a beneficialfunction.

BRIEF DESCRIPTION OF THE DRAWING

FIGS. 1, 2 and 3 are diagrammatic side elevations of intrauterinedevices embodying the invention.

Referring to FIG. 1, there is shown an intrauterine device 10 having abase or intersection 12 and a pair of arms 14 and 16 divering upwardlyand outwardly therefrom. As shown in U.S. Pat. Nos. 3,507,274 and3,811,435, the entire disclosures of which are incorporated herein byreference, the device comprises a resilient Y- or V-shaped resilientmember totally encased within a plastic or rubber material, preferablyclean-grade or medical-grade silicone rubber. Beads 18 and 20 at theends of arms 14 and 16, respectively, have curved side surfaces 22 and24, respectively, which are adapted to contact the adjacent sidewalls ofthe uterus when the intrauterine device is in position therein. Betweenarms 14 and 16 there is a membrane 30 having a portion thereof 32 whichextends, in rectangular fashion, above an imaginary line passing throughthe ends of arms 14 and 16. As set forth above, it is the function ofthe membrane to contact the adjacent flat surfaces of the uterus andthereby prevent nidation or implantation of a fertilized ovum. Portion32 permits the use of a single device for both nulliparous andmultiparous women since the device can be tailored (if desired) to fituteri of varying lengths. After determining the length of the uterusprior to insertion of the device, portion 32 of membrane 30 can besuitably cut to provide an intrauterine device of the desired length.Optionally, since the membrane is so thin as to be extremely flexible,the device can be used as is, in which case membrane portion 32 willnaturally fold back upon itself (i.e., toward intersection 12) as itcomes into contact with the fundus upon insertion. The device,therefore, is readily adaptable for smaller-sized uteri. Adjacent tointersection 12 there are flexible spurs or protuberance 34 and 36adapted tp prevent expulsion of the device from the uterus. These spursare optional and can be eliminated if desired. Connected to intersection12 is a string or tell-tale 38 which extends through the cervical os andis used to remove the device from the uterus when desired. Since string38 is of significantly smaller dimension than the flexible tail of U.S.Pat. Nos. 3,507,274 and 3,811,435, it permits easier insertion of theintrauterine device into the inserter therefor and, in addition, affordsless chance for infection or expulsion when the intrauterine device isin position within the uterus.

In FIGS. 2 and 3, like numerals are utilized to designate elementscommon with the device of FIG. 1. Referring to FIG. 2, it can be seenthat beads 18' and 20' are of substantially smaller dimension than thecorresponding beads of the device of FIG. 1. In addition, portion 32' ofmembrane 30 has slightly rounded side portions 40 and 42 which areintended to cover those portions of the uterus adjacent to the entranceof the fallopian tubes into the uterus. Referring to FIG. 3, it can beseen that the intrauterine device shown therein is of generally V-shapeand is adapted to contact a greater proportion of the uterine walls. Thedevice is also devoid of intersection 12 which, as set forth above,reduces dilation of the upper endocervical canal, thereby minimizingpartial expulsion of the device through the cervix. As with the deviceof FIG. 2, beads 18" and 20" are of smaller dimension than thecorresponding beads of the device of FIG. 1. These will provide thecurved, smooth surfaces for contacting the adjacent sidewalls of theuterus, but will be less painful to the patient (than the beads of thedevice of FIG. 1) upon insertion of the device through the cervix.

In the devices above, web portion 32 (or 32' or 32") extends about 0.5to about 1 cm. above the terminal ends of arms 14 and 16. This extensionprovides sufficient length to achieve the advantages set forth above.

In a further modification, one of arms 14 and 16 can be of slightlyshorter length than the other arm so, when the device is positionedwithin the inserter, the beads or bulbous end portions are aligned, onebelow the other, in essentially linear fashion. This minimizes the sizeand dimension of the leading edge of the device thereby reducing patientdiscomfort upon insertion.

While the present invention has been described with reference to aspecific embodiment thereof, it will be understood by those skilled inthis art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of theinvention. For example. the Y- or V-shaped member can be made ofpolyethylene or nylon, if desired, provided the material has the desiredresiliency over the anticipated period of use; the device can be used tocarry a progestogen (e.g., progesterone), elemental copper, zinc or asoluble nontoxic compound thereof, or other drug (e.g., anantigonadotrophin) to the uterine cavity to further enhance thecontraceptive effect thereof, etc. Additionally, modifications may bemade to adapt a particular situation, material, structural desirabilityor then-present objective to the spirit of this invention withoutdeparting from its essential teachings.

What is claimed is:
 1. An intrauterine device comprising a resilient Y-or V-shaped member, said resilient member having two arms gradually andcontinuously diverging upwardly and outwardly from the intersectionthereof adjacent the base portion of said resilient member; said armsbeing sufficiently resilient so said arms can be urged together duringpositioning of said intrauterine device in an inserter for insertingsaid intrauterine device into a uterus; a unitary flexible membraneextending between said arms, said membrane covering the entire areabetween said arms and extending above an imaginary line passing throughthe end of said arms a dimension sufficient to contact the fundus of auterus, the extending portion of said membrane terminating in asubstantially linear edge and covering a substantially rectangular areadefined by said end portions and said substantially linear edge and aflexible string attached to said intersection, said string being adaptedto extend outwardly through the cervix when said intrauterine device isin position within the uterus.
 2. The intrauterine device of claim 1wherein said resilient member comprises stainless steel wire encased ina plastic or rubber material.
 3. The intrauterine device of claim 2wherein said plastic rubber material comprises medical grade siliconerubber.
 4. The device of claim 1 further including a plurality offlexible spurs attached to said arms, said spurs adapted to prevent theexpulsion of said intrauterine device when said intrauterine device ispositioned within the uterus.
 5. The device of claim 1 wherein saidresilient member is encased in a medical grade or clean grade plastic orrubber material.